Recall Z-0669-2025— Hologic, Inc

Name: FDA recall Z-0669-2025
Creator: U.S. Food and Drug Administration
Published: 2022-10-10

Class II · Completed

Class II FDA medical device recall by Hologic, Inc, initiated 2022-10-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101. Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set.

Recalling firm: Hologic, Inc
Classification: Class II
Status: Completed
Initiated: 2022-10-10
Firm location: Marlborough, MA, United States

Product description

Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

Reason for recall

IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set

Data sourced from openFDA. This site is unofficial and independent of the FDA.